The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atheroscle… (NCT05217459) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
China128 participantsStarted 2022-07-04
Plain-language summary
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. 30 to 75 years of age;
✓. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
✓. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
✓. The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
✓. The target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm;
✓. mRS \< 3;
✓. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
✓. Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.
Exclusion criteria
✕. The target vessels was complete occlusion;
✕. \>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
What they're measuring
1
The incidence of In-stent restenosis within 6 months after operation
. Preoperative magnetic resonance only showed perforating infarction in the target lesion area;
✕. Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
✕. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
✕. CT showed Severe calcified lesions;
✕. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);